S.L. 458.35 · Pharmacovigilance Regulations (S.L. 458.35)
S.L. 458.35 Art. 39Effective date of changes.
Title II of Regulation (EC) No 726/2004;
Any change to the dates of submission and frequency of periodic safety update reports specified in the marketing authorisation as a result of the application of regulations 35, 36 and 37 shall take effect six months after the date of such publication.